Benefits and risks of adding oxaliplatin to adjuvant chemotherapy in patients with high-risk stage II colon cancer

Outcome	Results	Absolute effect estimates		Quality of evidence	Plain language summary
		FU + LV	FOLFOX
Grade 3 peripheral sensory neuropathy	RR: 69.0 (95% CI, 17.0 to 278.0) (2219 patients in one study during treatment)	2 per 1000	138 per 1000	Moderate*	FOLFOX worsens grade 3 peripheral sensory neuropathy during treatment
		Difference: 136 more per 1000 (95% CI, 32 more to 554 more)
OS	HR: 0.91 (95% CI, 0.61 to 1.36) (569 patients in one study) Follow-up median: 80 months	167 per 1000	153 per 1000	Low^¶	FOLFOX may have little or no effect on OS in patients at high risk of recurrence
		Difference: 14 fewer per 1000 (95% CI, 62 fewer to 53 more)
DFS	HR: 0.72 (95% CI, 0.51 to 1.01) (569 patients in one study) Follow-up median: 63 months	254 per 1000	190 per 1000	Low^¶	FOLFOX may have little or no effect on DFS in patients at high risk of recurrence
		Difference: 64 fewer per 1000 (95% CI, 115 fewer to 2 more)
TTR	HR: 0.62 (95% CI, 0.41 to 0.92) (569 patients in one study) Follow-up median: 63 months	212 per 1000	137 per 1000	Low^¶	FOLFOX may improve TTR in patients at high risk of recurrence
		Difference: 75 fewer per 1000 (95% CI, 119 fewer to 13 fewer)

FU: fluorouracil; LV: leucovorin calcium; FOLFOX: fluorouracil, leucovorin, and oxaliplatin; RR: relative risk; OS: overall survival; HR: hazard ratio; DFS: disease-free survival; TTR: time to recurrence; PSN: peripheral sensory neuropathy.
* Downgrade for wide CI. Grade 3 PSN during treatment was reported in 138 patients (12.5%) in the FOLFOX4 group and 0.2% of the patients in the LV 1 FU group. At 18 and 48 months, 0.7% of FOLFOX-treated patients experienced Grade 3 PSN.
¶ Indirectness: population includes stage III patients (MOSAIC trial, 2009). MOSAIC analyses conducted in high-risk subpopulation are considered exploratory.

From: Baxter NN, Kennedy EB, Bergsland E, et al. Adjuvant Therapy for Stage II Colon Cancer: ASCO Guideline Update. J Clin Oncol 2021. DOI: 10.1200/JCO.21.02538. Copyright © 2021 American Society of Clinical Oncology. Reproduced with permission from Wolters Kluwer Health. Unauthorized reproduction of this material is prohibited.

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